Dexamethasone phosphate disodium Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate dexamethasone phosphate disodium across diverse therapeutic applications, including renal transplantation, local drug delivery during cochlear implant procedures, and relapsed or refractory multiple myeloma. Spanning a Phase 4 study, a combined Phase 1/Phase 2 trial, and an interventional design with no applicable phase, these trials are sponsored by academic medical centers and industry partners, such as University Hospital Geneva, Icahn School of Medicine at Mount Sinai, and MED-EL Elektromedizinische Geräte GesmbH. All of these studies are currently listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05935293	Not yet recruiting	Renal Transplantation\|Dexmedetomidine	Eduardo Schiffer\|University Hospital Geneva	2024-12-01	Phase 4
NCT06142682	Not yet recruiting	Cochlear Implant	MED-EL Elektromedizinische Geräte GesmbH	2024-06-30	Not Applicable
NCT06351644	Not yet recruiting	Relapsed and/or Refractory Multiple Myeloma	Adriana Rossi\|Icahn School of Medicine at Mount Sinai	2024-06-03	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Dexamethasone phosphate disodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dexamethasone phosphate disodium selectively binds to and activates the glucocorticoid receptor, driving receptor translocation to the nucleus and downregulating pro-inflammatory transcriptional pathways and cellular oxidative stress. This resulting anti-inflammatory and immunosuppressive effect underlies its therapeutic utility in managing inflammatory responses in renal transplantation and cochlear implantation, as well as inhibiting malignant plasma cell growth in relapsed or refractory multiple myeloma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).